EMEA-001231-PIP02-13-M09

Table of contents

Key facts

Invented name
Samsca and associated names
Active substance
Tolvaptan
Therapeutic area
  • Endocrinology-Gynaecology-Fertility-Metabolism
  • Uro-nephrology
Decision number
P/0157/2022
PIP number
EMEA-001231-PIP02-13-M09
Pharmaceutical form(s)
  • Tablet
  • Oral suspension
Condition(s) / indication(s)
  • Treatment of dilutional hyponatraemia
  • Treatment of polycystic kidney disease
Route(s) of administration
Oral use
Contact for public enquiries
Otsuka Pharmaceutical Netherlands B.V.

E-mail: communications@otsuka-europe.com 
Tel. +44 2037475001

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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